1. Field of the Invention
This invention relates to an aqueous pharmaceutical composition containing nicardipine hydrochloride in a therapeutically effective amount suitable for parenteral administration, especially intraveneous administration.
2. Description of Related References
Nicardipine is a member of the class of drugs referred to as calcium channel blocking agents (also referred to as calcium entry blocking agents).
The chemical name for nicardipine, which is used primarily as its hydrochloride salt, is as follows:
2-(Benzylmethylamino)ethyl methyl 1,4-dihydro-2, PA0 6-dimethyl-4-(m-nitrophenyl)-3,5-pyridine-dicarboxylate monohydrochloride. PA0 (1) An almost immediate response may be obtained by administering by intravenous injection a solution, usually aqueous, of the drug; PA0 (2) The therapeutic response by a patient to a drug may be more readily controlled by administering the drug parenterally; and PA0 (3) A drug can be administered parenterally to a patient when it cannot be administered orally because of the unconscious or uncooperative state of the patient, or because of inactivation or lack of absorption in the intestinal tract. PA0 (a) a therapeutically effective amount of nicardipine hydrochloride; PA0 (b) a physiologically and pharmaceutically acceptable non-chloride compound effective to render the pharmaceutical composition isotonic; PA0 (c) a physiologically and pharmaceutically acceptable buffer in an amount effective to maintain the pH of the composition at about 3.0 to about 4.5; and PA0 (d) a pharmaceutically acceptable aqueous vehicle comprising at least a major proportion of water. PA0 (a) a physiologically and pharmaceutically acceptable non-chloride compound effective to render the pharmaceutical composition isotonic and PA0 (b) a physiologically and pharmaceutically acceptable buffer in an amount effective to maintain the pH of the pharmaceutical composition at about 3.0 to about 4.5.
Nicardipine hydrochloride, its preparation, and its use are described in U.S. Pat. No. 3,985,758 (Oct. 12, 1976).